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Search / Trial NCT05537454

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Launched by UNIVERSITY OF MINNESOTA · Sep 8, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to understand how stress in mothers affects the composition of their breast milk, and how these factors relate to the growth and development of preterm infants. The study will follow babies born between 28 and 34 weeks of pregnancy who are stable enough to participate. Researchers want to see how what mothers experience during pregnancy can influence the health and development of their babies, both while they are in the neonatal intensive care unit (NICU) and at four months of age.

To be eligible for this study, mothers need to be between 18 and 45 years old at the time of delivery, and their preterm infants must meet certain health criteria. Specifically, the babies should not have serious health issues like major birth defects or conditions that could affect their growth. If you decide to participate, you’ll help researchers gather important information that could improve care for preterm infants in the future. Your involvement could lead to better understanding and support for mothers and their babies during this critical time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • preterm infant born between 28 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
  • mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery
  • Exclusion Criteria:
  • infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
  • mothers: a) alcohol consumption \>1 drink per week or any tobacco consumption during pregnancy, b) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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